The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs)

NCT06373887 | Recruiting

• 1 other identifier: 2023-09-005A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes. Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue .

Conditions

Weight Loss

Keywords

Gut Microbiome; Weight Loss Diet

Outcome Measures

Primary Outcomes (1)

• Body weight loss/fat mass loss

  2 weeks to 2 months

Secondary Outcomes (1)

• microbiota change

  2 months

Study Arms (2)

Low carbohydrate diet

EXPERIMENTAL

Dietary Supplement: plant-based Low carbohydrate diet

Low fat diet arm

ACTIVE COMPARATOR

Dietary Supplement: plant-based Low low fat diet

Interventions

plant-based Low carbohydrate diet DIETARY_SUPPLEMENT

In the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight.

Low carbohydrate diet

plant-based Low low fat diet DIETARY_SUPPLEMENT

In the research, the high, medium, low carbohydrate degradation subjects were randomized to either plant-based Low carbohydrate diet or low fat diet to loss weight.

Low fat diet arm

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with BMI \>=24 overweight and obesity without chronic disease or medication use.

You may not qualify if:

• a) Medication history of diabetes, hypertension, dyslipidemia, and cardiovascular diseases within two months.
• b) Bodyweight change within three months before the study. (+4kg). c) Participate in weight loss programs in the preceding 12 months. d) Use ABX, PPI, NSAID, laxatives, oral contraceptives, and antipsychotics within two months.
• e) Previous operations history for managing obesity (bariatric procedures and gastric bypass operation).
• f) Current smoking: at least 20 monthly cigarettes for over half a year. g) Alcohol consumption (\> two glasses per day). h) Pregnancy, breastfeeding, chronic kidney dis-ease, autoimmune, viral chronic diseases (hepatitis C, B, HIV, etc.), and neoplastic diseases.
• i) Consumption of vegetarian or unusual diets. The Institutional Review Board approved all study protocols at TVGH.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single-blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: To compare the weight-loss efficacy of different carbohydrate degradation status under two different diet arm (low carbohydrate or low fat diet) to evaluate the benefits of initial gut microbiota profiling in precision weight loss dietary interventions.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: April 10, 2024
• Primary Completion: November 29, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)